Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.

Device Description

Stethophone v1 is an electronic stethoscope software application that operates on smartphones. Stethophone v1 allows for the capture and amplification of chest sounds that are listened in real-time or recorded, cloud storage of sound records, sound filtering for selected frequency ranges, and visualization to assist in sound analysis.

Stethophone v1 is designed to assist healthcare providers to hear and visualize heart and lung sounds during a physical examination of a patient as well as storing recorded sounds for later analysis. Stethophone v1 is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Key product features:

Acquiring sound through the smartphone microphone
Real-time listening of chest sounds
Recording of chest sounds
Two modes of sound visualization: oscillogram and spectrogram
Selecting among three sound filters for listening:
- Bell: Classic filter used for low frequency sounds
- Diaphraqm: Classic filter used for higher frequency sounds of heart and lungs
- Starling: Filter for listening to the full frequency of chest sounds

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the Stethophone v1 device meets them, based on the provided FDA 510(k) summary. I will extract the relevant information and present it in the requested format.

It's important to note that this document is a 510(k) summary for a substantial equivalence determination, not a full clinical study report. Therefore, some details typically found in a comprehensive clinical trial description (like specific statistical methods for power calculation, detailed blinding procedures, or a full MRMC breakdown) might not be present or as detailed as one would expect from a dedicated clinical study publication.

Acceptance Criteria and Device Performance

The document states that Sparrow Acoustics Inc. submitted performance testing information "to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria." However, it does not explicitly list a table of acceptance criteria with corresponding performance metrics. Instead, it describes various tests conducted to support safety and efficacy.

Based on the nature of the device (an electronic stethoscope software) and the information provided, the acceptance criteria would revolve around:

Acoustic Performance: Ability to accurately capture, amplify, and filter heart and lung sounds within specified frequency ranges.
Functional Performance: Real-time listening, recording, playback, sound visualization (oscillogram, spectrogram), filter selection, volume control, and smartphone compatibility.
Usability: Ease of use for healthcare providers.
Safety: No electrical safety or electromagnetic compatibility issues (due to being standalone software).

Given the absence of a specific table, the "reported device performance" is inferred from the claims of "substantially equivalent" and the successful completion of the described tests.

Here is a conceptual table based on the provided text, outlining the implied acceptance criteria and the claimed performance.

Table 1: Implied Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific (Implied) Acceptance Criteria	Reported Device Performance
Acoustic Performance	Capture and amplify sounds between 20 and 2000 Hz.	Stethophone v1 "picks up and amplifies the sound between 20 and 2000 Hz."
	Specific frequency emphasis for Bell filter (25-300 Hz).	Bell filter "emphasizes range from 25 to 300 Hz."
	Specific frequency emphasis for Diaphragm filter (170-850 Hz).	Diaphragm filter "emphasizes frequency spectrum range 170-850 Hz."
	Specific frequency emphasis for Starling filter (60-1400 Hz).	Starling filter "works between 60-1400 Hz."
Functional Performance	Real-time listening of chest sounds.	"Real-Time Auscultation: Yes" - Confirmed.
	Recording of chest sounds.	"Record and Playback Sounds: Yes" - Confirmed. Recording length of 20 seconds.
	Two modes of sound visualization (oscillogram and spectrogram)	"Sound Visualization: Yes" - Confirmed. "Available Sound Visualization: Spectrogram, oscillogram."
	Selection among three sound filters (Bell, Diaphragm, Starling).	"Filter Selection: Yes" - Confirmed. Offers three specific filters.
	Volume control functionality.	"Volume Control: Yes" - Confirmed.
	Compatibility with specified iPhone models.	Compatible with a broad range of iPhone models from 6s to 13 Pro Max.
Usability	User-friendly interface for healthcare providers.	"Usability and performance study conducted by an independent medical facility" was performed to support equivalence claims, implying satisfactory usability. No specific metrics like SUS scores or task completion rates are provided.
Safety	No electrical safety or electromagnetic compatibility risks.	"Not Applicable (Standalone Software). Therefore, there is no source of electrical safety or electromagnetic compatibility associated directly with the device."
Overall Equivalence	Functionally equivalent to predicate devices for intended use.	"The proposed device Stethophone v1 and the predicate devices Steth IO and Littmann 3200 share the same intended use, design, user functions and fundamental scientific operational technology. The devices are functionally the same." Differences do not affect safety/effectiveness.

Study Details

Here's a breakdown of the study details as presented in the 510(k) summary:

Sample sizes used for the test set and the data provenance:
- The document mentions "performance tests using an anechoic chamber," "internal tests run by a medical analysts' team," "tests involving external medical specialists with auscultation experience," and "a usability and performance study conducted by an independent medical facility."
- However, specific sample sizes (e.g., number of audio recordings, number of subjects for usability, etc.) for any of these test sets are NOT explicitly stated in this summary.
- Data Provenance: Not explicitly stated, but the company is Canadian (Sparrow Acoustics Inc., Lucasville, NS, Canada). The nature of the tests (internal, external specialists, independent facility) suggests some form of prospective testing for performance and usability. It does not mention retrospective data analysis.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document refers to "a medical analysts' team" and "external medical specialists with auscultation experience."
- The exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience" or "cardiologist") are NOT specified. It only indicates "auscultation experience," which is a broad term.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does NOT describe any specific adjudication method (like "2+1" or "3+1 consensus") for establishing ground truth from the medical analysts or specialists. It simply states that they were involved in internal and external testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- A formal MRMC comparative effectiveness study in the sense of comparing human readers with AI assistance versus without AI assistance was NOT described or implied.
- The testing focused on the device's standalone performance, its acoustic properties, and its usability, aiming to demonstrate substantial equivalence to predicate devices, not improvement of human readers. The device is described as a "decision support device" but the efficacy study is not structured as an MRMC human-in-the-loop study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, performance of the device's sound capturing, amplification, and filtering capabilities were evaluated, including "performance tests using an anechoic chamber." This can be considered a form of standalone testing for the device's acoustic properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the acoustic performance testing (e.g., anechoic chamber), the "ground truth" would be established by controlled sound inputs and calibrated measurement equipment.
- For the tests involving "medical analysts' team" and "external medical specialists," the ground truth likely involved the clinical judgment or consensus of these experts regarding the quality, clarity, and diagnostic utility of the sounds captured and presented by the Stethophone v1 compared to their auscultation experience with predicate devices. No pathology or outcomes data is mentioned.
The sample size for the training set:
- The Stethophone v1 is described as an "electronic stethoscope software application" that provides "sound filtering for selected frequency ranges, and visualization to assist in sound analysis." It is not described as an AI/ML algorithm that requires a training set in the traditional sense (i.e., for learning patterns for classification or prediction).
- It functions as an audio processing and visualization tool. Therefore, a training set in the context of machine learning is not applicable or mentioned for this device. Its "training" would be more akin to software development and acoustic engineering calibration.
How the ground truth for the training set was established:
- As there is no mention of a traditional machine learning "training set" for the Stethophone v1, this question is not applicable based on the provided document. The device's functionality relies on signal processing and displaying capabilities, not on learned patterns from a labelled dataset.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

March 29, 2023

Sparrow Acoustics Inc. Nadezda Ivanova Chief Product Officer 2416 Natura Drive Lucasville, NS B4B 0X3 Canada

Re: K222871

Trade/Device Name: Stethophone v1 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: September 21, 2022 Received: September 22, 2022

Dear Nadezda Ivanova:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222871

Device Name

Stethophone v 1

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a sans-serif font in a light blue color. To the right of the word "SPARROW" is a graphic of a bird inside of a circle with sound waves emanating from it. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller sans-serif font.

510(k) SUMMARY

1. Summary Date: September 21, 2022
1. Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada. B4B 0X3 Tel: +1 (902) 989-3908
1. Correspondent: Nadia Ivanova
1. Device Trade Name: Stethophone v1
1. Device Common Smartphone stethoscope Name:
1. Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
1. Intended Use/ Stethophone v1 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart and Indications for Use: lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.
1. Device Description: Stethophone v1 is an electronic stethoscope software application that operates on smartphones. Stethophone v1 allows for the capture and amplification of chest sounds

that are listened in real-time or recorded, cloud storage of sound records, sound filtering for selected frequency ranges, and visualization to assist in sound analysis.

Acquiring sound through the smartphone microphone ●
Real-time listening of chest sounds .
Recording of chest sounds .
Two modes of sound visualization: oscillogram and spectrogram ●
Selecting among three sound filters for listening: ●
- Bell: Classic filter used for low frequency sounds O
- Diaphraqm: Classic filter used for higher frequency sounds of O heart and lungs
- Starling: Filter for listening to the full frequency of chest sounds O

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Image /page/4/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a large, sans-serif font in a light blue color. To the right of the word "SPARROW" is a stylized image of a bird inside of a circle with sound waves emanating from it. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller, sans-serif font.

9.	Predicate Devices:	Steth IO® Smartphone Stethoscopeand Phonocardiogram, Model 1.0	3M™ Littmann® ElectronicStethoscope, Model 3200
		510(k) Number: K160016Manufacturer: StratoScientific, Inc.Product Code: DQDClassification: 870.1875(b)	510(k) Number: K083903Manufacturer: 3M CompanyProduct Code: DQDClassification: 870.1875(b)
10.	Comparison toPredicates:	The comparison chart below provides evidence to facilitate thesubstantial equivalence determination between Stethophone v1 to thepredicate devices with respect to intended use, technologicalcharacteristics, and principles of operation.

	Stethophone v1	Steth IO®(primary)	3M™ Littmann®Model 3200	Comments
Classification
Classification	Class II device	Class II device	Class II device	Same
Regulation	21 CFR870.1875(b)	21 CFR870.1875(b)	21 CFR870.1875(b)	Same
Product code	DQD	DQD	DQD	Same
Device	Stethoscope,Electronic	Stethoscope,Electronic	Stethoscope,Electronic	Same
FDA Clearance	Pending	K160016	K083903
Intended Use/Indications for Use
Intended Use/Indications forUse	Stethophone v1 isintended formedicaldiagnosticpurposes only. Itmay be used fordetection andamplification ofsounds from theheart and lungswith the use ofselectivefrequency ranges.It can be used onadults undergoingphysicalassessment.	The StratoScientificSteth IOStethoscope andPhonocardiogramModel 1.0 isintended formedical diagnosticpurposes only. Itmay be used for thedetection andamplification ofsounds from theheart, and lungswith the use ofselective frequencyranges. It has beentested for use onadults undergoing aphysicalassessment.	The 3M™Littmann®ElectronicStethoscope, Model3200 is intended formedical diagnosticpurposes only. Itmay be used for thedetection andamplification ofsounds from theheart, lungs,arteries, veins, andother internalorgans with the useof a selectivefrequency. It can beused on any personundergoing aphysicalassessment.	Substantiallyequivalent
Prescription/OTS	Prescription	Prescription	Prescription	Same
Population Type	Adults	Adults	All types of patients	Same with StethIO, narrowerpopulation thanLittmann 3200

				which doesn'taffect safety andperformance forthe proposedintended use
Principles of Operation
Form Factor	Device that isheld in theDoctor's hand isthe form of thesmartphone	Device that is heldin the Doctor'shand is the form ofthe smartphone	Similar to atraditionalstethoscope	Same as Steth IO.Different thanLittmann 3200,which doesn'taffect safety andperformance
DedicatedDevice vs.iPhone	Operates oniPhonesmartphone usingits hardware andoperating system	Operates oniPhone smartphoneusing its hardwareand operatingsystem	Dedicatedproprietaryhardware (chestpiece)	Same as Steth IO.Different thanLittmann 3200,which doesn'taffect safety andperformance
iPhone modelCompatibility	6s, 6S Plus, SE1st gen, 7, 7 Plus,8, 8 Plus, X, XS,XS MAX, XR, SE2 generation, 11,11 Pro, 11 ProMax, 12, 12 Pro,12 Mini, 12 ProMax, 13 mini, 13,13 Pro, 13 ProMax	iPhone 6, 7/8, 7+ or8+, X	N/A	Stethophone v1 isavailable for alarger number ofiPhone modelsthan Steth IO,which may affectavailability, butdoesn't affectsafety andperformance asstethoscopes
SoftwarePlatform	iOS	iOS	Windows, MacOS	Same as Steth IO.Different thanLittmann 3200,which may affectavailability, butdoesn't affectsafety andperformance asstethoscopes
Sound Type	Heart, lungs	Heart, lungs	Heart, lungs,arteries, veins, andother internalorgans	Same with StethIO, narrower thanLittmann 3200,which doesn'taffect safety andperformance forthe proposedintended use
Signal InputMethod	Uses microphoneof the smartphoneto acquire asound	Uses microphoneof the smartphoneto acquire a sound	Uses microphoneof the stethoscopeto acquire a sound	Same as Steth IO,equivalent toLittmann 3200
Audio OutputMethod	Headphones	Headphones	Eartubes witheartips	Same as Steth IO,equivalent toLittmann 3200
Record andPlaybackSounds	Yes	Yes	Yes	Same
Real-TimeAuscultation	Yes	Yes	Yes	Same
Filter Selection	Yes	Yes	Yes	Same
Digital SignalProcessing(DSP)	Yes	Yes	Yes	Same
Display	Smartphonescreen	Smartphone screen	LCD display of thedevice	Same as Steth IO,equivalent toLittmann 3200
SoundVisualization	Yes	Yes	Yes	Same
Technical Characteristics
FrequencyResponse	Stethophone v1picks up andamplifies thesound between20 and 2000 Hz.Based on theselected audiofilter, specificfrequency rangesare furtheremphasized:Bell filteremphasizesrange from 25 to300 HzDiaphragm filteremphasizesfrequencyspectrum range170-850 Hz,Starling filterworks between 60-1400 Hz	Steth IO has twofilters: Heart andLung. The specificfrequency filtrationof these filterscorresponds toStethophone's Bell(high-cut filter) andclosely toStethophone'sDiaphragm andStarling filters. Thiscorrespondence isbased on frequencyresponse curves.	The Bell modeamplifies soundsfrom 20 - 1000 HZ,but emphasizeslower frequencysounds between 20- 200Hz.The Diaphragmmode amplifiessounds from 20 -2000 Hz butemphasizes thesounds between100 - 500 Hz.The ExtendedRange modeamplifies soundsfrom 20 - 2000Hzsimilar to theDiaphragm Modebut provides moreLow-frequencyresponse between50 - 500Hz.	Substantiallyequivalent
Volume Control	Yes	Yes	Yes	Same
Battery	Uses a built-inbattery of asmartphone	Uses a built-inbattery of asmartphone	Uses a built-inbattery of achestpiece	Same as Steth IO,equivalent toLittmann 3200
RecordingLengths	20 sec	Up to 1 min	Maximum of 29seconds for on-board recording, upto 1 min forwireless recordingto computersoftware	SubstantiallyEquivalent,differences don'taffect safety andeffectiveness
Available SoundVisualization	Spectrogram,oscillogram	Spectrogram,oscillogram	Spectrogram,oscillogram	Same
Ability to Zoom	Yes	Yes	Yes	Same

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Image /page/5/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a light blue sans-serif font, with a stylized image of a bird in the middle of the second "R". Above the bird are three curved lines, resembling sound waves. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.

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Image /page/6/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the "O". Below the word "SPARROW", the word "ACOUSTICS" is written in smaller, light blue letters.

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Image /page/7/Picture/1 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in a light blue sans-serif font, with the "W" replaced by a stylized image of a bird inside of three concentric circles. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.

The proposed device Stethophone v1 and the predicate devices Steth IO and Littmann 3200 share the same intended use, design, user functions and fundamental scientific operational technology. The devices are functionally the same: all three devices capture, amplify the sound, use frequency filters, visualize via two types of graphs (oscillogram and spectrogram), store records and allow auscultating heart and lung sound in real time. Software comparison and their validation support the equivalency claim. Performance and usability comparison testing was performed to support the equivalence claims.

Sparrow Acoustics Inc. submitted performance testing information in this 11. Performance Data: 510(k) to demonstrate safety and efficacy of Stethophone v1, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination.
Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving external medical specialists with auscultation experience, as well as a usability and performance study conducted by an independent medical facility.
1. Biocompatibility Not Applicable (Standalone Software) Testing:
Sterilization & Shelf-Not Applicable (Standalone Software). Therefore, it is a non-sterile 13. life Testing: device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.
1. Electrical safety and Not Applicable (Standalone Software). Therefore, there is no source of electromagnetic risk for electrical safety or electromagnetic compatibility associated compatibility (EMC): directly with the device.
1. Animal Study: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
1. Human Clinical Clinical testing was not required to demonstrate the safety and Performance Testing: effectiveness of the device.
1. Statement of Stethophone v1 and the predicate devices Steth IO and Littmann 3200 Substantial share the same intended use, design, user functions and fundamental Equivalence: scientific operational technology. The devices are functionally the same. Software comparison and their validation support the equivalency claim. The differences that exist between the devices do not affect the relative safety and/or effectiveness.

Sparrow Acoustics believes the Stethophone v1 device and its predicates Steth IQ (Model 1.0) and 3M Littmann Electronic Stethoscope, Model 3200 used in conjunction with the Littmann StethAssist phonocardiogram software, are substantially equivalent.

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.